Characterization of Aortic Tissue at Reoperation

CryoLife Europa11 enrolled

Overview

This study will analyse factors contributing to cardiac re-operation to determine causative effects

This study will collect clinical data on the characteristics of aortic tissue on which BioGlue has been applied during a previous cardiovascular surgery. This is a post market surveillance study.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Aneurysm Aortic Dissection

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects undergoing an aortic re-operation * Subject has had BioGlue used during previous aortic surgery * Subject is willing and able to give written informed consent for participation Exclusion Criteria: * Subject with a history of vasculitis * Subject with active infection (endocarditis) * Subject with a history of chronic inflammatory condition which may have led to ongoing tissue damage * Subject with a history of auto immune disease

Locations (1)

S.Orsola Malpighi Hospital

Bologna, Italy

Outcomes

Primary Outcomes

The microscopic evaluation of the presence of BioGlue on aortic tissue

Time frame: "participants will be followed for the duration of their surgery, an expected average of 5 hours

Secondary Outcomes

Observation and characterization of BioGlue usage during the reoperation procedure

Time frame: "participants will be followed for the duration of their surgery, an expected average of 5 hours

Data from ClinicalTrials.gov

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